Sr. Compliance Auditor - Remote

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Responsibilities may include the following and other duties may be assigned.

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

Minimum Requirements

• Bachelor’s degree required
• Minimum of 4 years of relevant experience, or advanced degree with 2 years of experience

Nice to Have

• Broad Technical & QMS Knowledge
• Lean Manufacturing/ Greenbelt training
• Experience working with Suppliers, audit observations
• Lead Auditor experience/knowledge
• Problem solving ability
• Statistical training
• Prior medical device industry experience or other regulated industry such as pharma, aerospace, auto, etc.
• Medical device manufacturing industry experience, preferably ISO 13485.
• Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.
• ASQ CQE, CQA and/or CSQP certification preferred
• Possess a minimum …